Feature
Drug Regulation
Attacks on publicly funded trials: what happens when industry does not want to know the answer
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1701 (Published 01 April 2015) Cite this as: BMJ 2015;350:h1701- Deborah Cohen, investigations editor, The BMJ
As
Britain’s doctors and commissioners call for bevacizumab to be used
within the NHS to reduce the cost of treating wet age related macular
degeneration, an investigation by The BMJ reveals how the drug
industry hindered publicly funded trials comparing it with ranibizumab.
The investigation shows how difficult it can be to achieve independent
evaluation of drugs when industry’s business interests conflict with
public health.
Bevacizumab and ranibizumab are
monoclonal antibodies developed by biotechnology company Genentech:
bevacizumab for intravenous use in cancer, ranibizumab for intravitreal
treatment of eye disease. Roche subsequently acquired Genentech and has
the intellectual property rights to both drugs, although Novartis has
the rights to market ranibizumab in Europe. Roche has so far declined to
apply for a licence for bevacizumab to be used in eye disease.
Philip
Rosenfeld, professor of ophthalmology at the Bascom Palmer Eye
Institute in Florida, was involved in the early trials of ranibizumab
and pioneered the use of bevacizumab. He maintains that, although owned
by the same company, bevacizumab was seen as an economic threat to the
ranibizumab franchise.
Genentech had always encouraged
its researchers to publish all their data. Rosenfeld said, “It was
obvious from their published data that both drugs were derived from the
same molecule that acts by inhibiting vascular endothelial growth factor
(VEGF), preventing blood vessel growth.” He proposed a clinical trial
of bevacizumab in patients with wet AMD, but he says Genentech wasn’t
interested. So in 2004, with the help of his institution, Rosenfeld
raised funds and ran a clinical trial himself.
The results were remarkable and immediate, he says, explaining how patients’ vision improved. He and the director of his …
